Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melissa Dahir, Creighton University
ClinicalTrials.gov Identifier:
NCT01697345
First received: September 26, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.


Condition Intervention Phase
Breast Cancer
Vaginal Dryness
Dyspareunia
Sexual Health Quality of Life
Drug: Testosterone
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Total Female Sexual Function Index (FSFI) Score [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.

  • FSFI Desire Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.

  • FSFI Arousal Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.

  • FSFI Lubrication Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.

  • FSFI Orgasm Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.

  • FSFI Satisfaction Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.

  • FSFI Pain Domain [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.


Secondary Outcome Measures:
  • Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2013
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal Testosterone
Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
Drug: Testosterone

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with breast cancer
  • Currently taking an aromatase inhibitor (AI)
  • Age > 50 years of age
  • Postmenopausal, or two years since last menstrual cycle
  • Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse
  • Changes in sexual health quality of life/sexual functioning since starting AI therapy

Exclusion Criteria:

  • The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
  • A known sensitivity to medications containing testosterone
  • The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697345

Locations
United States, Nebraska
Nebraska Cancer Specialists/Midwest Cancer Center - Legacy
Omaha, Nebraska, United States, 68130
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Melissa A Dahir, DNP Creighton University
Study Chair: Dianne Travers-Gustafson, PhD Creighton University
Study Director: Robert Langdon, MD Nebraska Cancer Specialists
  More Information

No publications provided

Responsible Party: Melissa Dahir, Principal Investigator, Creighton University
ClinicalTrials.gov Identifier: NCT01697345     History of Changes
Other Study ID Numbers: MelissaDahir
Study First Received: September 26, 2012
Results First Received: August 15, 2013
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Vaginal Testosterone
Vaginal atrophy
Female Sexual Dysfunction
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Dyspareunia
Breast Diseases
Genital Diseases, Female
Genital Diseases, Male
Mental Disorders
Neoplasms
Neoplasms by Site
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Skin Diseases
Aromatase Inhibitors
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014